Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00000658 · ClinicalTrials.gov registry record · Phase 3

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

A Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
250
Enrollment target
20
Study locations

NCT00000658: Completed Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000658 is a Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 250 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00000658, a Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
250 participants
Enrollment target
20
Study locations

Study Summary

To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.

Conditions Studied

HIV Infections Lymphoma, Non-Hodgkin

Interventions

  • DRUG Cyclophosphamide
  • DRUG Allopurinol
  • DRUG Doxorubicin hydrochloride
  • DRUG Bleomycin sulfate
  • DRUG Vincristine sulfate

Study Locations (20)

New York

  • SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
  • Beth Israel Med. Ctr. (Mt. Sinai) - New York
  • NY Univ. HIV/AIDS CRS - New York
  • Memorial Sloan-Kettering Cancer Ctr. - New York
  • Univ. of Rochester ACTG CRS - Rochester

California

  • USC CRS - Los Angeles
  • UCLA CARE Center CRS - Los Angeles
  • Ucsf Aids Crs - San Francisco

Massachusetts

  • Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston
  • Beth Israel Deaconess - East Campus A0102 CRS - Boston
  • Bmc Actg Crs - Boston

Illinois

  • Northwestern University CRS - Chicago
  • Rush Univ. Med. Ctr. ACTG CRS - Chicago

Ohio

  • Case CRS - Cleveland
  • The Ohio State Univ. AIDS CRS - Columbus

Colorado

  • University of Colorado Hospital CRS - Aurora

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis

Maryland

  • Johns Hopkins Adult AIDS CRS - Baltimore

Trial Details

FieldValue
Enrollment Target 250 participants
Est. Completion 1996-02
Phase Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00000658 record still lists

NCT00000658 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (44% lower).

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00000658 names 20 study sites across 10 states, led by New York, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00000658 about?

NCT00000658 is a clinical study titled "A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma". To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence ...

What is the current status of trial NCT00000658?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. Estimated completion is 1996-02.

What conditions does trial NCT00000658 study?

This clinical trial studies the following conditions: HIV Infections, Lymphoma, Non-Hodgkin.

What interventions are being tested in trial NCT00000658?

The interventions under investigation include: Cyclophosphamide (DRUG), Allopurinol (DRUG), Doxorubicin hydrochloride (DRUG), Bleomycin sulfate (DRUG), Vincristine sulfate (DRUG).

Who is sponsoring clinical trial NCT00000658?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000658 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00000658's enrollment target sits among peer trials

250 139th of 542 higher than 396 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00483249 · 250 participants · NA

    Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

  • NCT00777712 · 250 participants

    Mechanisms Underlying Impaired Diabetic Wound Healing

  • NCT01451502 · 250 participants · NA

    Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

  • NCT01771718 · 250 participants

    Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy

Related registry views

Source: ClinicalTrials.gov NCT00000658, the US trial registry maintained by the National Library of Medicine. NCT00000658 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.